Bariatric Surgery, Obesity
Conditions
Keywords
Obesity, Bariatric Surgery, No invasive intra-auricular vagus nerve stimulation, Weight loss, Autonomic nervous system
Brief summary
Faced with the current obesity epidemic, new avenues of research into effective weight loss must be developed. Among the possible actions on obesity, vagus nerve stimulation has been shown in several studies to be effective in treating epilepsy or depression, at the same time inducing weight loss in those patients. Vagus nerve stimulation has also shown to be effective on weight loss in experimental animal studies. Vagus nerve stimulation has never been attempted in obese patients awaiting bariatric surgery.
Detailed description
The primary objective is to demonstrate the benefit of transcutaneous vagus nerve stimulation in obese subjects awaiting surgery. Secondary objectives include, among others, the risk factors related to obesity, systemic micro-inflammation, insulin and lipid profile.
Interventions
DEVICENeuroCoach II Stim
A noninvasive vagus nerve stimulator consists of two components. An electrode is placed in the left ear concha and will be used by the patient for 4-5 hours per day in segments of 1 hour minimum. For this intervention, the stimulations are active.
Sponsors
Fondation de l'Avenir
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Any obese patient consulting for bariatric surgery with BMI ≥ 35 and comorbidities or with BMI ≥ 40 * Consent Form signed
Exclusion criteria
* Permanent atrial fibrillation * Patient on treatment that could influence measurement of Autonomic Nervus System (ANS) activity (eg. anti-arrhythmics). * For patients previously operated (by any technique), an interval of at least 6 months since the surgery must be observed * Pacemaker * Serious cardiac pathology * History of myocardial infarction * History of Stroke * Severe respiratory insufficiency * Allergy in the Rhodium and in the gold * Surgery of the vagus nerve * Pregnant patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | at 6 months | the weight (kg) is measured after 6 months of noninvasive stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic inflammation | at 3, 6, 9 and 12 months | Markers of systemic inflammation will be measured on centrifuged serum for C-reactive protein (CRP) and by immuno microassay using the Luminex method for InterLeukin (IL)-6 and IL-17. |
| Apnea-hypopnea index (AHI) | at 3, 6, 9 and 12 months | AHI is analyzed by a polysomnography in an outpatient setting. |
| Patient Health Questionnaire-9 (PHQ-9) | at 3, 6, 9 and 12 months | It is a anxiety scale |
| Blood pressure | at 1, 3, 6, 9 and 12 months | — |
| Octanoylated ghrelin hormone | at 3, 6, 9 and 12 months | Patients will be subjected to blood samplings |
| Glucagon-like peptide-1 hormone (GLP1) | at 3, 6, 9 and 12 months | Patients will be subjected to blood samplings |
| Heart rate variability (HRV) | at 3, 6, 9 and 12 months | HRV is measured by a 24H-Holter Electrocardiography (ECG). It is a composite outcome : * the standard deviation of NN intervals (SDNN) * the proportion of number of pairs of successive NNs that differ by more than 50 ms, divided by total number of NNs (pNN50) * high frequency (HF) * low frequency (LF) * very low frequency (VLF) |
| Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride) | at 3, 6, 9 and 12 months | Patients will be subjected to blood samplings |
| Serum insulin level | at 3, 6, 9 and 12 months | Patients will be subjected to blood samplings |
| Glycemia | at 3, 6, 9 and 12 months | Patients will be subjected to blood samplings |
| Glycated hemoglobin | at 3, 6, 9 and 12 months | Patients will be subjected to blood samplings |
| Adverse effects | at 12 months | Local and systemic adverse effects will be described at each consultation. In particular, patients will be informed that they can call the investigator if they have any questions or to report any effects that seem unusual. |
| Peptide tyrosine tyrosine hormone (PYY) | at 3, 6, 9 and 12 months | Patients will be subjected to blood samplings |
Countries
France
Outcome results
None listed